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Unilateral and Bilateral Sacrospinous Ligament Fixation for Pelvic Prolapse: A Nonconcurrent Cohort Comparison

Jones, Christopher M. MD; Hatch, Kenneth D. MD; Harrigill, Keith MD

Resident Award Article: Gynecology

Objective To compare postoperative anatomic cure rates in women treated with bilateral sacrospinous ligament fixation (SSLF) or unilateral SSLF for pelvic prolapse. Secondary outcome measures of morbidity were compared.

Methods One hundred and three women with pelvic prolapse treated surgically between July 1, 1990, and September 31, 1999, were divided into two groups: patients with bilateral SSLF (n = 62) and patients with unilateral SSLF (n = 41). Demographic, clinical, and outcome data were compared.

Results There were similar anatomic cure rates regardless of SSLF type (37/41 women [90.2%], unilateral, compared with 53/62 [85.5%], bilateral;P = 0.56). Specific anatomic defects occurred with similar frequencies between the groups. Women in the unilateral SSLF group had more blood loss and longer operative times than did those in the bilateral group. There were similar rates of transfusion, readmission, cystitis, postoperative incontinence, urinary retention, febrile morbidity, and length of stay between the two groups.

Conclusion Unilateral and bilateral SSLF techniques produce similar rates of anatomic cure.

Obstetrics and Gynecology Department, University of Arizona Health Sciences Center, Tucson, Arizona

Received for publication July 5, 2000; accepted September 25, 2000.

Correspondence: Kenneth D. Hatch, MD, Professor and Chair, Department of Obstetrics and Gynecology, University of Arizona Health Sciences Center, 1501 North Campbell Avenue, Tucson, AZ 85724.

E-mail: khatch@u.arizona.edu

We are pleased to publish the article that has won the 2000 Resident Paper Award in the gynecology category: “Unilateral And Bilateral Sacrospinous Ligament Fixation for Pelvic Prolapse: A Nonconcurrent Cohort Comparison.” As winner, Dr. Christopher Jones will receive a complimentary 1-year subscription to Journal of Pelvic Surgery. The winning article in the colorectal surgery category, “The Management of Microlaparoscopic Bowel Injuries: Two Approaches” by Stephanie R. Fugate, DO, will be published in the March/April issue. Readers will find guidelines for the 2001 awards in this issue. We were pleased by the response to our first resident paper awards contest and encourage residents in urologic, colorectal and gynecological surgery programs to submit their papers for the 2001 contest.

Raymond A. Lee, MD Editor-in-Chief

Symptomatic vaginal vault prolapse occurs with 0.2 to 43% of hysterectomies, 1 and in most series the incidence has been less than 5%. 2 The definitive management of vaginal vault prolapse is surgical, and successful treatment is comprised of restoration of anatomy, re-establishment of normal function, and relief of symptoms. 3

Vaginal and abdominal surgical approaches for vaginal vault prolapse have similar efficacy, 4 although the vaginal approach produces shorter hospital stays, less discomfort, and allows repair of coexisting defects through the same incision. 3 Transvaginal suspension techniques for prolapse have involved attaching the vaginal cuff to the sacrotuberous, uterosacral, or sacrospinous ligaments. 5,6,7 The most common current transvaginal procedure described in the literature is the unilateral sacrospinous ligament fixation (SSLF) technique. SSLF may also be used prophylactically for total procidentia at hysterectomy. Cruikshank and Cox recommend SSLF at hysterectomy if there the uterosacral-cardinal ligaments are lax and the vaginal apex descends to or beyond the introitus. 8

Because unilateral SSLF is extensively performed, morbidity and outcome data are available. 3,4,8–16 A recent review of the literature describes outcome data for over 1000 patients. 21 Bilateral techniques have been developed to provide symmetry and dual points of support while avoiding deviation. 17,18 Outcome data from bilateral SSLFs are limited, with the largest series containing 42 patients. 19 Shull and colleagues reported bilateral attachment of the vaginal vault, albeit to the iliococcygeal fascia. 20

It is not clear that the success rate with bilateral fixation differs from the 8 to 94% objective cure rate reported for unilateral SSLF (mean, 75%). 21 This data has not been investigated in the literature. In a feasibility study, Pohl and Frattarelli were unable to complete 35% of attempted bilateral sacrospinous fixations. They suggest that bilateral fixation requires significant intraoperative judgment and may place the vault under such tension as to compromise the repair, especially of the anterior compartment. 17 The bilateral technique may increase morbidity. Pohl and Frattarelli found an additional 25 to 50 ml of blood loss and 20 to 30 minutes of operative time compared with unilateral SSLF. 17

We tested the null hypothesis that women with pelvic organ prolapse treated with bilateral SSLF have the same frequency of postoperative anatomic cure as women treated with unilateral SSLF. Secondary outcomes of morbidity measures were compared between the groups.

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Materials and Methods

We performed a nonconcurrent cohort study of women treated with SSLF for symptomatic pelvic prolapse between July 1, 1990, and September 31, 1999. Billing databases at three hospitals in Tucson, Arizona, were searched for SSLF procedure codes. A second search of these databases for patients with International Classification of Diseases (ICD)-9 codes for either vaginal vault prolapse or uterovaginal prolapse was performed. The two lists were merged to identify all patients with a diagnosis of vaginal vault or pelvic organ prolapse who were treated with SSLF. Patients treated by any surgeon other than those involved in this study were excluded, and the list was further restricted to the specified dates. The indications for the performance of SSLF were demonstrable uterovaginal or vaginal vault prolapse and symptoms severe enough that the patient requested surgical correction. There were no other exclusion criteria applied. Finally, 103 subjects were identified and then divided into those undergoing unilateral and bilateral SSLF.

The surgical technique for both groups was similar. Entry into the rectovaginal septal space began with excision of a triangular segment of perineal skin and lower vagina. Midline dissection was then extended to the vaginal apex, defined as the posterior cuff for patients undergoing a concomitant hysterectomy or the uterosacral crease for patients with a previous hysterectomy. A finger was inserted into the rectum to identify the proper pararectal space and to prevent rectal injury. The vaginal mucosa was then sharply and bluntly dissected off of the rectovaginal septal plate. Either the right lateral space (unilateral SSLF) or both lateral spaces (bilateral SSLF) were entered by dissecting the vaginal mucosa at the lateral sulci down to the ischial spines.

The bladder attachments at the apex were mobilized to allow safe placement of apical stitches at a subsequent step. This was followed by repair of the anterior compartment. After removing a vaginal mucosal segment, Kelly-Kennedy plication stitches were placed to increase the urethrovesical neck. The Kelly-Kennedy technique is routinely performed during anterior repair at our institution.

Anterior compartment defects were repaired with the bladder pillars approximated in the midline and sutured to the vaginal apex. The attenuated uterosacral ligaments were identified at the apex and a helical stitch with two knot throws of delayed absorbable suture were placed to secure the suture. Exposure of the sacrospinous ligaments was facilitated by using Breisky-Navritil retractors and a lighted suction device.

The previously placed (uterosacral ligament-vaginal apex) sutures were then passed through one (unilateral SSLF) or both (bilateral SSLF) sacrospinous ligaments 2 cm medial to the spine. Posterior repair was begun before the suture ends were tied. The posterior compartment was closed by reapproximating the rectovaginal septal facial plate, harvested as the vaginal mucosa was dissected off the rectum. This fascia was attached to the vaginal apex with three delayed absorbable sutures and the sacrospinous ligament sutures were then tied. This elevated the vaginal apex restoring vaginal anatomic normalcy.

Demographic data of the two groups were compared to ensure similarity. Data included age, weight, parity, smoking status, urethral mobility, degree of prolapse of the compartments, patient-reported incontinence, previous anterior or posterior colporrhaphy, previous vaginal suspension procedure, previous incontinence procedure, presence or absence of uterus, and route of previous hysterectomy, if applicable. Intraoperative outcome data included estimated blood loss, operative time, gastrointestinal injury, and urinary tract injury. Concurrent procedures were compared for differences in distribution. For the purposes of this study, Kelly-Kennedy plication is not considered an incontinence procedure.

Early outcome data included length of stay, transfusion, febrile morbidity, urinary retention, urinary tract infection, and readmission. Late outcome date included fistula formation, anatomic compartment defects, incontinence, and recurrence. Length of follow-up of the two groups was also compared.

We defined “smokers” as those patients smoking one cigarette or more daily; patients who stopped smoking before their surgery were not considered smokers for the purposes of this study. Hypermobility of the urethra was diagnosed if the cotton swab test was greater than 30°. Pelvic organ prolapse was graded as described by Stenchever:22 first degree is prolapse into the vagina, second degree is prolapse to the introitus, and third degree is out through the introitus.

Postoperative exams were performed and recorded by the primary surgeons and the house staff working directly under their supervision. Febrile morbidity was diagnosed when there were persistent temperatures greater than or equal to 38.0°C more than 24 hours after surgery requiring antibiotic treatment. Urinary tract infections were diagnosed when there were culture-proven bacturia or if urinalysis was consistent with urinary tract infection and clinical signs of urinary tract infection were present. Urinary retention was diagnosed when the patient failed at least one voiding trial in the hospital and was subsequently discharged with an indwelling catheter.

Readmissions within 1 week of surgery resulting from surgical complications were tracked. Postoperative incontinence was diagnosed when the patient complained of subjective incontinence more than 5 weeks following surgery. Anterior, posterior, and apical compartment anatomic defects were identified at the postoperative visit. Anatomic cure was defined as no anatomic compartment defects or recurrence at postoperative examination.

Continuous data were compared using the unpaired Student t-test, substituting the Mann-Whitney test when the standard deviations were unequal. We used the Fisher exact test for dichotomous data. Analyses were two tailed, with significance set at P < 0.05. Statistical analysis was carried out using Instat v2.01 (Graphpad Software, San Diego, CA) and SPSS v6.1 (SPSS, Inc., Chicago, Illinois). The sample size was calculated as a difference of proportions for expected anatomic defects or recurrence rates. The mean cure rate for unilateral SSLF procedures, defined as no demonstrable anatomic defects at follow-up examination, was approximately 75%. 21 Assuming an α of 0.05 and a β of 0.2, a sample size of 41 subjects in each arm was needed to detect a 23% increase in postoperative anatomic cure rates as a result of bilateral SSLF.

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Results

Data were analyzed from 103 patients; 62 patients (60%) underwent bilateral suspensions and 41 (40%) underwent unilateral suspensions. The mean follow-up rate was the same between groups (8.6 months ± 2.42 SEM, unilateral, compared with 4.6 months ± 0.91 SEM, bilateral, P = 0.85). The groups were demographically similar (Table 1). There were no statistically significant differences in the distribution of preoperative anatomic defects (Table 2) or concurrent surgical procedures (Table 3).

Table 1

Table 1

Table 2

Table 2

Table 3

Table 3

The miscellaneous procedures in the unilateral group included urethral caruncle excision (1), diagnostic laparoscopy (1), vulvectomy (1), laparoscopic assisted vaginal hysterectomy (1), labial scar excision (1), trachelectomy (1), Burch colpourethropexy (1), and vaginoplasty (1). The miscellaneous procedures in the bilateral group included Gartner duct excision (1), inclusion cyst excision (1), vaginectomy (1), and Burch colpourethropexy (1). There were eight miscellaneous procedures performed in the unilateral group and four in the bilateral group. The difference in miscellaneous procedures performed was not statistically significant (P = 0.06).

Clinical outcomes are shown in Table 4. There were no statistically significant differences in frequencies of specific postoperative anatomic defects between the two groups. There were no statistically significant differences in morbidity between the groups except for the estimated blood loss and the operative time, both of which were elevated in the unilateral SSLF group. There were no cases of gastrointestinal tract injury, urinary tract injury, or fistula formation in either group. Miscellaneous complications included myocardial infarction (1), pneumonia (1), pyelonephritis (1), ileus (1), and pelvic cellulitis/abscess (2). Five miscellaneous complications in the bilateral group and one in the unilateral group were noted. The difference in miscellaneous complication rates was not statistically significant (P = 0.40).

Table 4

Table 4

The primary outcome in this study was the anatomic cure rate. The overall rate of postoperative anatomic cure in the unilateral SSLF group (37/41 women: 90.2%) was not different than that of those undergoing bilateral SSLF (53/62 women: 85.5%;P = 0.56); 18/41 patients in the unilateral group and 37/62 patients in the bilateral group had more than one postoperative visit after the standard 6-week postoperative examination. Three patients subsequently underwent reoperation for their postoperative anatomic defects (two patients from the unilateral group and one from the bilateral group).

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Discussion

The primary goal of this study was to compare postoperative anatomic outcomes for patients undergoing unilateral and bilateral SSLF. Our bias was that bilateral SSLF would lower rates of recurrence by suspending the vagina using two points of support instead of one. This expectation was based in part on an observation by Peters and Christensen, who found recurrences on the contralateral side in six patients treated with unilateral SSLF. 23 We also felt that by providing symmetry, bilateral fixation could potentially improve postoperative anterior and posterior compartment defect rates.

The postoperative anatomic cure rates in the unilateral group and bilateral group were similar at 90.2 and 85.5%, respectively, which are comparable to previously reported rates. 3,8,11,13,20,23 If there is a significant difference in anatomic outcomes between the two groups it is likely to be sufficiently small and only demonstrated in a study involving a longer follow-up period and larger sample size. However, using standard definitions for diagnosis of anatomic defects, we were unable to demonstrate a significant difference in the short-term recurrence or anatomic defect rate. Of the seven patients who had previously undergone vaginal suspension procedure, two had postoperative defects (28.6%). Three patients were sufficiently symptomatic (one in bilateral group and two in the unilateral group) to request surgical correction. In the bilateral group this was 1.6% of patients. This is a slightly lower rate of reoperation than found in the literature for unilateral SSLF (2.9%). 21

A reported concern with the bilateral technique is that it will predispose to postoperative anterior compartment defects. 17,24 The results of this study do not support that concern. The rate of postoperative anterior defects was similar (11.3% bilateral versus 9.8% unilateral, P = 1.00). These rates are comparable to the existing literature. 3,13,14 We did not find that bilateral fixation compromised the anterior compartment, which may be attributable to our technique of establishing anatomic continuity between all compartments by attaching them together at the vaginal apex. We also recognize the importance of identifying and correcting even minimal anterior defects because the suspension procedure will direct the vaginal vault posteriorly and place the anterior compartment at risk. 9 We were able to complete all bilateral procedures attempted.

For the bilateral technique to be accepted as an alternative to the unilateral technique, morbidity must be comparable. The bilateral technique has previously been associated with clinically insignificant increases in blood loss and operative time. 17 In our series, operative time and estimated blood loss were unexpectedly increased in the unilateral group. We attribute this to the primary surgeon uniformly performing the bilateral technique in the latter part of the study, and thus becoming more efficient with experience. There was a trend toward increased transfusion rates in the bilateral group, but it was not statistically significant. This trend may be explained by examining the patients in the bilateral group who were transfused. One patient had a myelodysplastic disorder, one had a preoperative hematocrit of 29%, and another patient suffered a myocardial infarction. This last patient had a prolonged hospital course and subsequently underwent a coronary artery bypass procedure.

An interesting finding was that the overall incidence of urinary retention in this study was 39.8%. There was not a significant difference between the unilateral and the bilateral groups. The high rate of retention may in part be related to our definition. It may not be reasonable for patients to void without dysfunction before discharge with current short hospital stays, especially given that the majority of patients undergo concomitant anterior colporrhaphy. The fact that we almost routinely perform a Kelly-Kennedy plication during anterior colporrhaphy may also help explain the rate of urinary retention. We do not routinely place a suprapubic catheter, although this may need to be considered in light of the high rate of urinary retention and the 11.7% rate of postoperative cystitis. Peters and Christenson raise the concern that vaginal vault suspension may pull the bladder neck open and predispose to incontinence. 23 We noted that subjective incontinence was improved postoperatively, suggesting that SSLF does not contribute to clinically significant incontinence.

Our study is limited by its retrospective nature, its relatively small number of patients, and the short term for follow-up. However, we are not aware of any existing literature that directly compares unilateral to bilateral SSLF. We provide outcome data on the largest group of patients undergoing bilateral SSLF collected to date. Morbidity rates with bilateral SSLF do not appear to be higher than those with unilateral SSLF. Therefore, we believe that this study supports the use of bilateral SSLF as a viable alternative to unilateral SSLF. Future efforts should obtain prospective data and gather long-term follow-up data from a larger pool of patients to clarify potential anatomic outcome differences.

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References

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